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Alcohol Use, UnspecifiedPhase 4NCT04331704

ANCHORS Alcohol & Sexual Health Study: UH3 Project

A Phase 4 study testing PrEP acronym (pre-exposure prophylaxis), Initial Web Survey and Interactive Voice Response (IVR) monitoring in people with Alcohol Use, Unspecified and Substance Use, run by University of Florida at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

80 young adult men will complete an initial survey and receive 1 of 2 types of alcohol and sexual health education and information to encourage prevention of alcohol-related problems, HIV and other sexually transmitted infections (STIs). Read more about this study

Who is it for?
Ages 18 to 30 years, men onlyHealthy volunteers can take part
What is being tested?
PrEP acronym (pre-exposure prophylaxis), Initial Web Survey and Interactive Voice Response (IVR) monitoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteUnited States
Study dates
12 Jan 2021to 30 Jun 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Ability to read and write English
  • Consumption of 5 or more drinks per drinks in a day at least once in the past 30-days
  • Sexual intercourse with another man without condom use at least once in the past 30 days
  • HIV seronegative at medical screening
  • Report currently taking PrEP willingness to take PrEP

Who cannot join

  • History of clinically significant withdrawal from alcohol, defined as any one of the following: a) a lifetime history of seizures, delirium, or hallucinations during alcohol withdrawal; b) a Clinical Institute Withdrawal Assessment scale score > 8; c) a report of drinking to avoid withdrawal symptoms in the past 12 months; or d) a lifetime history of medical treatment for withdrawal.
  • Self report injection drug use
  • DSM-5 criteria for moderate or severe current substance use disorder besides alcohol and nicotine.
  • Serious psychiatric symptoms
  • Use of medications that interfere with PrEP including diuretics, nephrotoxic drugs, non-steroidal anti-inflammatory drugs, antiretroviral drugs or other drugs that may interfere with tenofovir excretion
  • Active hepatitis B infection
  • The following medical exclusions: serious or life-threatening conditions; inadequate biochemical, hepatic, hematologic, or pancreatic function according to laboratory testing
  • Participant reports currently taking injectable PrEP

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Robert L. Cook, PhD contact

(352) 273-5869

cookrl@ufl.edu

United States1 site, 1 recruiting

  • University of Florida

    Gainesville, Florida, 32611

    Robert L. Cook, PhD, 352-273-5869, cookrl@ufl.edu

    Robert L. Cook, PhD

    Recruiting

Other trials in United States

About this study

Official title: Advancing New Computer-based Health Outreach Regarding Sexual Behavior (ANCHORS) Study: UH3 Project

80 young adult men will complete an initial survey and receive 1 of 2 types of alcohol and sexual health education and information to encourage prevention of alcohol-related problems, HIV and other sexually transmitted infections (STIs). Participants will then take pre-exposure prophylaxis (PrEP) for HIV prevention and complete a daily 5-minute, telephone-based interactive voice response (IVR) assessment of alcohol/substance use, sexual behavior and PrEP taking for 30 days. Medication will all be active PrEP. There is no placebo control in this study. Follow-up will occur after 30-days and 6-months later.

Being tested
PrEP acronym (pre-exposure prophylaxis), Initial Web Survey, Interactive Voice Response (IVR) monitoring, Educational material on alcohol and sexual health behavior, Interactive Voice Response (IVR) assessment with personalized information
Medical subject headings
Alcohol Drinking, Substance-Related Disorders, Sexual Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrEP acronym (pre-exposure prophylaxis)Drug

    Also called emtricitabine/tenofovir disoproxil fumarate

    A daily tablet containing 245 mg of tenofovir disoproxil fumarate and 200 mg emtricitabine (Truvada; Gilead Sciences) for up to 30 days.

  • Initial Web SurveyBehavioural

    Web-based assessment questions regarding alcohol and other substance use and sexual health behaviors

  • Interactive Voice Response (IVR) monitoringBehavioural

    Daily telephone-based assessment on alcohol and other substance use, sexual health behavior and PrEP taking

  • Educational material on alcohol and sexual health behaviorBehavioural

    Educational material to provide information, resources and techniques to enhance awareness regarding alcohol and other substance use, along with sexual health behavior.

  • Interactive Voice Response (IVR) assessment with personalized informationBehavioural

    Daily telephone-based assessment on alcohol and other substance use, sexual health behavior and PrEP taking with personalized and information based on daily IVR responses

  • Personalized information based on web-based survey responses & standardized informationBehavioural

    Personalized and information on alcohol use and sexual health behavior based on responses to the web-based survey along with standardized information.

Study groups in NCT04331704
Study groupRoleWhat they receive
Personalized InformationExperimentalParticipants randomized to this condition will complete a web-based questionnaire and then receive personalized information regarding their alcohol use and sexual health behavior. They will complete daily, phone-based IVR monitoring for assessment purposes and receive further personalized information based on their responses.
Receives: Drug: PrEP acronym (pre-exposure prophylaxis); Behavioral: Initial Web Survey; Behavioral: Interactive Voice Response (IVR) assessment with personalized information; Behavioral: Personalized information based on web-based survey responses & standardized information
Educational InformationActive comparatorParticipants randomized to this condition will complete a web-based questionnaire and then receive educational material regarding their alcohol use and sexual health behavior. They will complete daily phone-based IVR monitoring for assessment purposes.
Receives: Drug: PrEP acronym (pre-exposure prophylaxis); Behavioral: Initial Web Survey; Behavioral: Interactive Voice Response (IVR) monitoring; Behavioral: Educational material on alcohol and sexual health behavior

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in quantity of drinks per week

    Change in self-reported number of alcoholic drinks per week

    Measured: Baseline up to 1 and 6-month follow-up

  2. Change in peak drinking quantity

    Change in self-reported number of alcoholic drinks consumed on one's peak drinking day in the past 30 days

    Measured: Baseline up to 1 and 6-month follow-up

  3. PrEP levels in blood at end of intervention period

    Determine whether or not participants have therapeutic levels of PrEP in their blood samples

    Measured: 1-month follow-up

  4. PrEP levels in blood at the end of the follow-up period

    Determine whether or not participants have therapeutic levels of PrEP in their blood samples

    Measured: 6-month follow-up

  5. PrEP prescription fill with supporting documentation in the intervention period

    Observation of whether or not a participant opts to fill a prescription for PrEP in the intervention period based on pharmacy documentation

    Measured: during the 1-month intervention period

  6. PrEP prescription fills with supporting documentation during the follow-up period

    Observation of prescription fills for PrEP with documentation during the follow-up period based on pharmacy documentation

    Measured: the 6-month follow-up period

Secondary outcomes (4)

  1. Reduced alcohol use as a reason for adherence to PrEP

    Test reductions in alcohol use following the intervention as a possible mechanism underlying relationships between the intervention and adherence to PrEP

    Measured: Baseline up to 1 and 6-month follow-up

  2. Change in perceived risk of HIV as a reason for adherence to PrEP

    Test increase in Perceived Risk of HIV Scale score following the intervention as a possible mechanism underlying relationships between the intervention and adherence to PrEP

    Measured: Baseline up to 1 and 6-month follow-up

  3. Change in sexual risk behavior as a reason for adherence to PrEP

    Test reduction in Risk Assessment Battery score following the intervention as a possible mechanism underlying relationships between the intervention and adherence to PrEP

    Measured: Baseline up to 1 and 6-month follow-up

  4. Increased motivation for behavior change as a reason for adherence to PrEP

    Test increased score on the Contemplation Ladder for motivation to avoid risky sexual health behavior, to take PrEP and to reduce drinking following the intervention as a possible mechanism underlying relationships between the intervention and adherence to PrEP

    Measured: Baseline up to 1 and 6-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2020
  2. Study start12 Jan 2021
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04331704
Sponsor's protocol ID
IRB201902818-N
Other IDs
UH3AA026214, OCR31862, F31AA028751
Status last verified
Jul 2025
First submitted
27 Mar 2020
Last updated
10 Jul 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing PrEP acronym (pre-exposure prophylaxis), Initial Web Survey and Interactive Voice Response (IVR) monitoring in people with Alcohol Use, Unspecified and Substance Use, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Robert L. Cook, PhD ((352) 273-5869, cookrl@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in quantity of drinks per week (time frame: Baseline up to 1 and 6-month follow-up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04331704.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.

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